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  U.S. Department of Health and Human Services | National Institutes of Health

Exhibit Overview

Biologics Regulation and Research: The People and Work of Buildings 29 & 29A

Buildings 29 and 29A are nationally significant to the history of medicine and public health because within the laboratories of Buildings 29 and 29A, the NIH and then FDA staff helped to conquer some of the deadliest infectious diseases. In their regulatory role they had the national responsibility to license vaccines, antitoxins, blood products, and other biologics to ensure their safety and effectiveness. To support this role, they did scientific research which resulted in the development of important standards and even new vaccines. Some of the most well-known scientists and administrators of the twentieth century worked in these buildings, first for the NIH and then for the Food and Drug Administration (FDA) and 22 of them are profiled here in the Biographies section. This online exhibition will share information about the research, regulations, and work conducted in these two laboratory buildings between 1960 and 2014. A variety of diseases, vaccines, and other biologics are discussed here, with links to articles and other websites for further research. While the buildings are no longer in use, their legendary staff and their important work lives on.

Transfer to FDA and Biological Products Review

The legislative history leading to the codification of the 1902 Biologics Control Act into the 1944 Public Health Service Act included a proposal that biological products have ‘efficaciousness’ in addition to the safety, potency, and purity requirements already in the statute.  However, the additional requirement of efficaciousness was not carried into the 1944 Act.  In March 1972 GAO reported that DBS had not required effectiveness of biological products despite the fact that they were also ‘drugs’ under the statutory definition, and drugs had to be effective as well as safe under the 1962 Drug Amendments to the Food, Drug, and Cosmetic Act.  In the same month NIH announced its intention to review all of its biological products and issued a call for substantial evidence of effectiveness, the standard that was applied to drugs.  During a May 1972 Congressional hearing HEW Secretary Elliott Richardson announced that DBS should be transferred to FDA, and the following month he did just that.

In February 1973 FDA finalized plans to conduct a systematic efficacy review of all licensed biological products, modeled on its review of over-the-counter drug products that had been launched the previous year.  Commissioner Charles Edwards appointed six advisory panels of experts that would review the evidence and assign each biological product to one of the following categories:  safe and effective; unsafe and/or ineffective;  requiring further study but to remain available in the interim;  and lacking sufficient data to be determined safe and effective and recommended for market removal.  Much as the case with new drugs, the proof of effectiveness would be expected to derive from adequate and well-controlled investigations.  And much like the case with drugs, the review lasted decades.  Along the way, though, some licenses have been revoked, such as in 1977 when FDA announced its intention to revoke the licenses of eight skin tests for tuberculosis, diphtheria, and other diseases and conditions.

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